安普泽生物医药 ee jobs (salary & requirements)

职责描述：
 Develop maintain validation management procedures related SOPs
起草及维护验证管理程序及相关SOP
 Maintain VMP develop validation plan, writing qualification & validation documen-tation
维护验证主计划和验证计划，起草及协调确认/验证文件
 Manage equipment vendors testing engineers to ensure validation executed in ac-cordance with GMP pre-defined quality system requirements
管理设备供应商和测试工程师，确保验证执行过程符合GMP和已定义质量体系的要求
 Be responsible finvestigation, correction of deviations during validation execution.
负责验证执行中的偏差的调查及纠正
 Execution of proper administration system of validation documents
执行良好的验证文档管理
 Provide validation regulatory support throughout design, construction commis-sioning stages. Provide support to site digital transformation project
在项目设计、建造和调试阶段提供验证和法规方面的支持，对工厂数字化项目提供技术支持
 Knowledge & Skills: Good understanding of GAMP 5 Chinese & international GMP对GAMP5及中国和国际GMP有较好的理解
 Perform system risk assessment manage process & cleaning validation
执行系统风险评估及管理工艺，清洁验证
 Other jobs assigned by manager
其他分配任务
任职要求：
Bachelabove, majin chemistry/pharmacy other related areas.
生物、医药、化学、分析相关专业，至少大学本科以上（含）
10 years more working experience within biotechnolo-gy pharmaceutical, minimum 3 years of experience on validation management, skilled in document develop-ment. Knowledge of sterile product manufacturing validation experience in biopharmaceutical is preferred.
在生物技术或医药10年以上工作经验，至少3年验证管理的经验，擅长文件编制，有无菌产品制造知识或生物制药验证工作经验者优先考虑。